When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
SmPC updates include:
- Addition of ‘w/w to product name (section 1) - Addition of the following to section 2: ‘ Also contains Cetyl alcohol 8.0% w/w’ & ‘For a full list of excipients,see section 6.6’ - Inclusion of reference to nasal and throat irritation in section 4.8
- Addition of the following to section 2: ‘ Also contains Cetyl alcohol 8.0% w/w’ & ‘For a full list of excipients,see section 6.6’ - Inclusion of reference to nasal and throat irritation in section 4.8
- Inclusion of reference to nasal and throat irritation in section 4.8
For information the following details the changes to section 4.4 of the SmPC:
Add: Not for use under tight bandages. The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should be washed 30 minutes after application. And to remove: After applying Axsain Cream with the fingers, hands should be washed immediately.
Not for use under tight bandages.
The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should be washed 30 minutes after application.
And to remove:
After applying Axsain Cream with the fingers, hands should be washed immediately.